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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 510 drug applications between 11 June 2026 and 17 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 55 drug names.

2026/06/11 – 2026/06/17

Period
2026/06/11 to 2026/06/17, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
510
Drugs with new generic filings (by drug name, de-duplicated)
55
Accepted this week, now under review
137

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

510filings, 73 of them generic

By application type

Application typeFilings
Supplement314
New drug87
Generic73
Import20
Import re-registration11
Unspecified5

By drug type

Drug typeFilings
Chemical drug250
TCM175
Therapeutic biologic76
Prophylactic biologic7
Biologic2

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

55 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

285 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Mei Hua Yi (Hebei) Pharmaceutical Co., Ltd. romanized990
2Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized980
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
4Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized880
5Pfizer Inc.630
6Hubei Mei Si Chuang Pharma Co., Ltd. romanized620
7Amgen Inc.610
8Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized550
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
10Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

143 this week

AcceptedDrugApplicants
2026/06/17Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2600145 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/06/17Import · Class 1 HDP-101 · No verified English nameJXSL2600144 Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd.
2026/06/17Import · Class 1 ASP2138注射液 · No verified English nameJXSL2600143 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/06/17Generic · Class 3 Succinylcholine Chloride InjectionCYHS2601444 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601443 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2026/06/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601442 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2026/06/17Generic · Class 3 Hydrotalcite SuspensionCYHS2601441 Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Methotrexate TabletsCYHS2601436 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601435 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2601434 Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Ferrous Succinate TabletsCYHS2601433 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized
2026/06/17Generic · Class 3 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2601431 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Potassium Chloride Oral SolutionCYHS2601430 Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600073 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/17Generic · Class 3 贝派度酸依折麦布片 · No verified English nameCYHL2600072 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2026/06/17New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2600095 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2026/06/17New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2600094 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2026/06/17New drug · Class 3.3 司库奇尤单抗注射液 · No verified English nameCXSS2600093 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/06/17New drug · Class 2.2 注射用瑞卡西单抗 · No verified English nameCXSL2600655 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/06/17New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600654 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/17New drug · Class 1 猫毛膜剂 · No verified English nameCXSL2600653 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/06/17New drug · Class 1 猫毛膜剂 · No verified English nameCXSL2600652 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/06/17New drug · Class 1 猫毛膜剂 · No verified English nameCXSL2600651 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/06/17New drug · Class 1 猫毛膜剂 · No verified English nameCXSL2600650 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/06/17New drug · Class 1 猫毛膜剂 · No verified English nameCXSL2600649 Zhejiang Wo Wu Bio Technology Co., Ltd. romanized
2026/06/17New drug · Class 2.2 吸附无细胞百白破(组分)联合疫苗 · No verified English nameCXSL2600648 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized
2026/06/17New drug · Class 2.2 吸附组分无细胞百白破(减剂量)联合疫苗 · No verified English nameCXSL2600647 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized
2026/06/17New drug · Class 1 脐带间充质干细胞注射液 · No verified English nameCXSL2600646 Shandong Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized; Guangdong Bai Hong Gan Xi Bao Zai Sheng Yi Xue Co., Ltd. romanized
2026/06/17New drug · Class 1 LPM526000133富马酸盐胶囊 · No verified English nameCXHL2600739 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized
2026/06/17New drug · Class 1 LPM526000133富马酸盐胶囊 · No verified English nameCXHL2600738 Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized

113 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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